The Food and Drug Administration (FDA) took long-overdue steps yesterday to curb the overuse of antibiotics in food producing animals which has been definitively linked to the crisis of antibiotic resistance in humans by numerous health organizations worldwide.
Laura Rogers, the director of the Pew Campaign on Human Health and Industrial Farming, told me that “[t]his is the most sweeping action the agency has undertaken in this area, as this covers all antibiotics used in meat and poultry production that are important to human health.” Evidence linking antibiotic resistance in humans to overuse of antibiotics in animal farms primarily to promote animal growth — not to treat illness — has been mounting for decades. The FDA recognized the problem more than four decades ago, attempted to address it in 1977, but ultimately took little definitive action. The recent NRDC lawsuit, in which a Federal Judge ordered the FDA to finish what it stared in 1977, and the agency’s announcement yesterday may begin to wean the industry off its drug addiction.
The agency announced a three-pronged voluntary approach to the overuse of antibiotics in food producing animals which it has worked on for over two years. First, it made final the draft guidance, initially issued in 2010, on the The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals. The crucial aspect of this guidance is the agency’s recognition that “the use of medically important antimicrobial drugs in food-producing animals for production purposes does not represent a judicious use of these drugs” and that “production use indications such as ‘increased rate of weight gain’ or ‘improved feed efficiency’ are no longer appropriate for the approved conditions of use for medically important antimicrobial drugs.
Second, the FDA is issuing for public comment draft guidance for drug manufacturers. Doctor Gail Hansen, resident veterinarian at the Pew Campaign with a Master’s degree in Public Health, told me that this measure will serve as the roadmap for compliance for drug manufacturers producing new animal drugs. The draft guidance, among other things, includes a recommendation for greater veterinarian oversight of antibiotics. This FDA guidance states that the agency believes:
it is important to include veterinary oversight in the use of antimicrobial new animal drugs to assure their appropriate and judicious use. Veterinarians play a critical role in the diagnosis of disease and in the decision-making process related to instituting measures to treat, control, or prevent disease. … FDA believes that the judicious use of medically important antimicrobial new animal drugs in the feed or water of food-producing animals needs the scientific and clinical training of a licensed veterinarian.
Lastly, the agency seeks comments on the Veterinary Feed Directive (VFD) regulations which propose to update and streamline the use and distributions of certain drugs permitted only under the professional supervision of a licensed veterinarian.
The meat industry has recognized since the 1940s that “[s]ubtherapeutic antibiotics (STAs) can promote growth, particularly in poultry and hogs, by improving nutrient absorption and by depressing the growth of organisms that compete for nutrients,thereby increasing feed efficiency,” but it will eventually have to make changes to its practices. Whereas up until now large scale operators (aka CAFOs) have thrived by maximizing “efficiency” by squeezing more animals into smaller spaces and drugging animals with antibiotics, they will now have to seek alternatives to those methods. This probably means better hygiene and greater reliance on vaccination. Animal advocates will also tell you that requiring industrial animal producers to be less dependent on drugs ultimately should mean giving animals more room to live in. It remains to be seen, however, whether large operators embrace this truth. Interestingly, a 2009 United States Department of Agriculture report noted that reducing the subtherapeutic use of antibiotics may also have broader positive implications for food safety.
Farms not providing STAs [subtherapeutic antibiotics] instead used extensive testing and expanded sanitation controls. Specifically, farms that did not provide STAs usually tested their birds (for avian influenza, salmonella, and other pathogens), and their feed (for salmonella), while farms that relied on STAs were much less likely to test. Farms that did not provide STAs were also much more likely to fully clean out and sanitize their houses after every flock, and typically were required to have a HACCP (Hazard Analysis and Critical Control Point) plan in place to guide food safety actions.
The steps taken by the FDA to address the overuse of antibiotics, while significant, still leave a lot of important questions unanswered. For example, Dr. Hansen, while applauding the FDA for wanting to implement more vet control over the use and administration of antibiotics, is concerned about the implementation of these recommendations which are not spelled out in agency guidance. Similarly, Laura Rogers, while supporting the agency’s move towards curbing the overuse of antibiotics, pointed out that big loopholes still exist in the guidance, particularly with the lack of definition on what constitutes preventative use of such drugs. The Pew Campaign, for example, would have liked to see antibiotics be a measure of last resort, a decision made by a veterinarian, where other methods have failed rather than be a “substitute for poor management,” which is the polite way of describing the current deplorable conditions endured by farm animals in most factory farms.
Of course the fact that the FDA guidance are voluntarily is troublesome and many consumer and health advocates will criticize the FDA’s process as painfully slow and favoring the industry. No regulations means no violations or sanctions should stakeholders fail to comply. The FDA does a lot of its work through voluntary measures and it could be argued that industry has an incentive to fall in line to avoid the imposition of regulations. Exactly what constitutes compliance and success here, however, remains undefined.
In response to my questions regarding the agency’s plans to monitor compliance, the FDA directed me to the agency’s Q&A section on its website which provided a vague pro-business response. Among other things, the agency states that it “does not want the recommendations to negatively impact animal health or disrupt the animal agriculture industry,” and that it “recognizes the need to collaborate with the animal health and animal producer communities on strategies for minimizing animal health impacts or industry disruption.” While the agency plans to monitor and evaluate the progress of its voluntary strategy over the next three years, no specifics on those measures are identified.
The agency, however, is not off the hook from compliance with the court order issued in the NRDC case. Avinash Kar, an attorney with NRDC told me that:
The voluntary guidelines do not affect FDA’s obligations under the judge’s order–to hold a hearing and withdraw approval for the use of penicillin and tetracyclines in animal feed unless drug manufacturers prove in an administrative hearing that such uses are safe for human health. This is a high bar to meet. As the court pointed out in its opinion, the science connecting antibiotic use in livestock to antibiotic resistance has only gotten stronger in the last 35 years since FDA first made findings on the subject.
The judge ruled in his opinion that non-binding recommendations are not sufficient to meet FDA’s legal obligations concerning penicillin and tetracyclines.